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FDA Requires Release Testing of Ranitidine and Nizatidine Due to NDMA Impurity

On December 4, 2019, FDA announced that ongoing testing of OTC and prescription ranitidine (commonly known as Zantac) and nizatidine products is required due to the detection of an N-nitrosodimethylamine  (NDMA) impurity.

NDMA Impurity Testing in Ranitidine (Zantac) and Nizatidine

Several weeks ago, FDA launched an investigation to:

  • Understand the source of the NDMA impurity in common heartburn medications
  • Provide information to patients and consumers

FDA asked manufacturers to conduct their own laboratory testing to identify levels of NDMA, and also asked them to submit samples to be tested by FDA scientists.

Further NDMA Impurity Screening of Ranitidine and Nizatidine is Now Required

FDA has asked manufacturers of ranitidine and nizatidine medications to expand testing for NDMA to all lots prior to making the product available to consumers and patients.

If NDMA is found to be above the acceptable daily intake limit, the manufacturer is obligated to inform FDA and should not release the lot for consumer use.  The acceptable daily intake limit for NDMA is 96 nanograms per day or 0.32 parts per million for ranitidine.

Bringing Ranitidine Medications Back to the Market with NDMA Testing

Several manufacturers have voluntarily recalled ranitidine medications, and information can be found on FDA’s recall webpage. Some companies recalled medication due to levels of NDMA above the acceptable daily intake limit, and others recalled ranitidine drugs due to the potential of an NDMA impurity.

Manufacturers can establish levels of NDMA in ranitidine and nizatidine medications by testing each lot of product prior to release. If NDMA is found to be below the acceptable daily intake limit during lot release testing, their ranitidine medications may become available to patients and consumers.

Safe Alternatives to Ranitidine

At this time, FDA’s testing has not found NDMA in a number medicines used for stomach acid conditions, including Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole).

Additionally, FDA’s evaluation of the manufacturing processes indicate that these products should not contain NDMA. Meanwhile, the Agency is assessing other H2 blockers and proton pump inhibitors (PPIs) that may also be used as ranitidine alternatives.

How Can Avomeen Help Test Ranitidine for NDMA Impurities?

Avomeen’s industry and scientific experts have tested a number of lots for the FDA’s initial NDMA impurity investigation, and are ready to analyze lots of ranitidine and nizatidine product for NDMA levels prior to release to consumers and patients. Speak to a regulatory expert or get a quote for NDMA impurity testing.

Additional Resources

We explore the initial FDA statement and investigation into the NDMA impurities in ranitidine in our blog, New FDA Statement on NDMA Impurities in Drug Products.

NDMA impurities have been found in metformin drugs outside the U.S. Our blog explores the FDA’s investigation into NDMA impurities in metformin.

 

 

Our featured blogger is Katie Morgan, Avomeen’s Senior Director of Marketing and Business Development. She has over a decade of experience establishing and implementing client development strategies, and her broad range of experience includes strategic contract development and marketing and content development.

Learn more about Katie’s expertise and experience.